FDA Authorizes 11 ZYN ULTRA Nicotine Pouches – Total PMTA Approvals Reach 43

More ZYN Variants Gain FDA Marketing Approval in US

The US Food and Drug Administration (FDA) has authorised the marketing of 11 new ZYN ULTRA nicotine pouch products, including an 11mg variant, following scientific review under its premarket tobacco product application (PMTA) pathway.The products, manufactured by Swedish Match USA, a subsidiary of Philip Morris International (PMI), comprise ten 9mg variants and one 11mg variant. They include Smooth, Cool Mint, Spearmint, Wintergreen, Peppermint,…

FDA Authorizes Harm Reduction Products

After years of dragging its feet—and running afoul of the law—on tobacco harm reduction (THR), the Food and Drug Administration (FDA) is finally reversing course. On August 21, Reuters reported that the FDA “authorized ​11 [ZYN] nicotine pouch products recently launched ‌by Philip Morris, citing lower levels of harmful constituents compared with other oral and smokeless ​tobacco products.” The […]

FDA Authorizes 11 ZYN ULTRA Nicotine Pouches – Total PMTA Approvals Reach 43

On August 21, 2026, the U.S. Food and Drug Administration (FDA) official FDA announcement authorized 11 ZYN ULTRA nicotine pouch products from Swedish Match USA for U.S. marketing through the Premarket Tobacco Product Application (PMTA) pathway. The authorization covers 10 products labeled with 9 mg of nicotine and one product labeled with 11 mg. The decision forms part of the FDA’s nicotine pouch PMTA pilot program, which was established to str…